Influence of Preoperative Support on Anxiety, Pain and Satisfaction With Postoperative Analgesia in Children and Adolescents After Thoracic Surgeries: a Randomized Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in anxiety intensity scores
研究概览
简要总结
The aim of this study was to analyze a relationship between information support provided by an interdisciplinary team and the levels of anxiety, pain and satisfaction with postoperative analgesia in children and adolescents subjected to thoracic surgeries.
详细描述
The study included 112 consecutive pediatric patients qualified for lateral thoracotomy or Ravitch procedure. The subjects were randomized to the control group (n=56) provided with a routine preoperative information from a nurse, and the experimental group (n=56) offered additional psychological consultation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •thoracic surgery (lateral thoracotomy or Ravitch procedure),
- •the American Society of Anesthesiologists score 1 or 2.
排除标准
- •presence of a mental disorder,
- •anticancer treatment,
- •preoperative pain,
- •problems with verbal communication ,
- •lack of postoperative drainage of the chest.
结局指标
主要结局
Change in anxiety intensity scores
时间窗: day prior to surgery, postoperative day 2
Anxiety was determined with a Polish version of the self-inventory, either for children between 9 and 14 years of age, i.e. State-Trait Anxiety Inventory for Children (STAI-C; range: 20-60 pts) or for adolescents, i.e. State-Trait Anxiety Inventory (STAI; range: 20-80 pts). The instrument consisting of two separate 20-item scales measuring state and trait anxiety. In this study, the levels of anxiety were determined twice: one day prior to surgery (both trait and state anxiety) and 48 h after the procedure (only state anxiety). The results were expressed as sten scores, from 1-10 (1-4 = low level of anxiety, 5-6 = moderate level of anxiety, \>7 = high level of anxiety).
次要结局
- Pain intensity scores during deep breathing(postoperative hours: 1, 2, 4, 11, 24, 48)
- Pain intensity scores during coughing(postoperative hours: 1, 2, 4, 11, 24, 48)
- Patient satisfaction(postoperative day 2)
- Pain intensity scores at rest(postoperative hours: 1, 2, 4, 11, 24, 48)